Trial Outcomes & Findings for Rod Sensitivity in Age-related Macular Degeneration (AMD) and Retinitis Pigmentosa (RP) (NCT NCT03322930)
NCT ID: NCT03322930
Last Updated: 2019-12-23
Results Overview
Number of participants with rod sensitivity measured in decibels at multiple retinal locations within the central retina
Recruitment status
COMPLETED
Target enrollment
40 participants
Primary outcome timeframe
through study completion, an average of 1 year
Results posted on
2019-12-23
Participant Flow
patients recruited from medical clinic (Texas Retina Associates)
Participant milestones
| Measure |
Patients With a Diagnosis of Retinitis Pigmentosa
patients with a diagnosis of retinitis pigmentosa
Rod sensitivity: diagnostic test for rod loss in central retina
|
Patients With Intermediate Age-related Macular Degeneration
patients with a diagnosis of intermediate AMD
Rod sensitivity: diagnostic test for rod loss in central retina
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Rod Sensitivity in Age-related Macular Degeneration (AMD) and Retinitis Pigmentosa (RP)
Baseline characteristics by cohort
| Measure |
Patients With a Diagnosis of Retinitis Pigmentosa
n=20 Participants
patients with a diagnosis of retinitis pigmentosa
Rod sensitivity: diagnostic test for rod loss in central retina
|
Patients With a Diagnosis of Intermediate AMD
n=20 Participants
patients with a diagnosis of intermediate AMD
Rod sensitivity: diagnostic test for rod loss in central retina
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
40 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: through study completion, an average of 1 yearNumber of participants with rod sensitivity measured in decibels at multiple retinal locations within the central retina
Outcome measures
| Measure |
Patients With a Diagnosis of Retinitis Pigmentosa
n=20 Participants
patients with a diagnosis of retinitis pigmentosa
Rod sensitivity: diagnostic test for rod loss in central retina
|
Patients With a Diagnosis of Intermediate AMD
n=20 Participants
patients with a diagnosis of intermediate AMD
Rod sensitivity: diagnostic test for rod loss in central retina
|
|---|---|---|
|
Rod Sensitivity Within the Central Retina as Measured on the Nidek MP-3S
|
7 Participants
|
20 Participants
|
Adverse Events
Patients With a Diagnosis of Retinitis Pigmentosa
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Patients With a Diagnosis of Intermediate AMD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place